DOTmed HealthCare Business News: Let’s stop the dangerous waiting game


The U.S. Food and Drug Administration’s (FDA) conclusion last month that unregistered and unknown third-parties who service medical imaging and other devices require no additional regulation was not the news that manufacturers expected to hear. While we agree with many FDA findings, we reach a far different conclusion on this one. When the original equipment manufacturer (OEM) services an imaging device, there are regulations imposed in the interest of patient safety: Why should others who service medical devices be treated differently and held to a lower standard? Are not patients the primary focus here?

We already know that third-parties are not required to report adverse events observed in the course of servicing medical imaging and other devices. The FDA report found, in part, that there is not enough evidence to conclude that third-party servicing poses a widespread public health concern, but that’s because there is no evidence collected. It is reasonable to surmise that the evidence that is available is the information provided by the OEMs that they are required by law to report. Clearly, the available evidence is incomplete.

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